Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia
Information source: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tumor of Ear, Nose and Throat
Intervention: Remifentanil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centre Hospitalier Universitaire de Besancon Official(s) and/or principal investigator(s): Sébastien Pili Floury, MD , PhD, Principal Investigator, Affiliation: CHRU Besançon Angéline Chopard-Guillemin, MD, Principal Investigator, Affiliation: CHRU Besançon Amélie Jurine, MD, Principal Investigator, Affiliation: CHRU Besançon Guillaume Besch, MD, Principal Investigator, Affiliation: CHRU Besançon Arnaud Causeret, MD, Principal Investigator, Affiliation: CHRU Besançon
Summary
The most important considerations for the general anesthesia in diagnostic panendoscopy of
the upper airway is the maintenance of a patient's airway for optimal surgical exposure,
adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques
with preserved spontaneous ventilation and total intravenous administration of anesthetic
drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often
considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous
studies suggested that adding remifentanil to propofol could improve the conditions for
laryngoscopy and tracheal intubation.
The aim of this study is to assess the impact of propofol remifentanil general anesthesia
compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of
the upper airway.
Clinical Details
Official title: Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway
Secondary outcome: DeltaHRmaxDeltaHRmin DeltaMAPmin DeltaMAPmax Proportion of patients presenting at least one episode of moderate hypoxemia Proportion of patients presenting at least one episode of severe hypoxemia Proportion of patients requiring invasive mechanical ventilation Proportion of patients presenting surgery complications
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Elective diagnostic panendoscopy of the upper airway
- Age > 18 and < 80 years old
- American Society of Anesthesiology (ASA) score equal to 1, 2, or 3 with a stable
condition
- Written inform consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- Age < 18 years old or inability to give informed consent
- Known anaphylaxis to remifentanil or propofol
- Long term opioid use, drug abuse
- Predictive criterion of impossible mask ventilation or intubation
- Chronic respiratory failure requiring oxygen therapy
Locations and Contacts
Centre Hospitalier Régional Universitaire, Besançon 25000, France
CHRU Besançon, Besançon 25000, France
Additional Information
Related publications: Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23. Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.
Starting date: June 2009
Last updated: March 19, 2014
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